Docs push back on step therapy in Medicare Advantage

Key clinical point: Medicare Advantage plans will now be able to implement step therapy on Part B drugs.

Major finding: Only new prescriptions will be eligible for step therapy; existing treatments will not be disrupted.

Study details: CMS made the decision to reverse previously existing policy on step therapy as part of an ongoing effort to help lower the cost of prescription drugs.

Disclosures: There were no relevant disclosures.

Source: Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage;

A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.

Dr. David I. Daikh

The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”

Doctors aren’t having it.

“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.

“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”

The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.

By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.

Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”

The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.

CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.

The American Society of Clinical Oncology also voiced its objection.

Dr. Barbara L. McAneny

“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”